Medical device recalls
Device recalls are the largest single group in this archive, because the FDA logs corrections and removals as well as outright withdrawals. Many are handled entirely between the manufacturer and a hospital and need nothing from a patient. Each notice states who has to act.
13,634 stored notices, reported between Jun 20, 2012 and Sep 9, 2026. Newest first.
Reported Aug 18, 2021
Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carl Zeiss Meditec, Inc.
FDA (openFDA device enforcement)
Reported Aug 18, 2021
Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cordis Corporation
FDA (openFDA device enforcement)
Reported Aug 18, 2021
Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
FDA (openFDA device enforcement)
Reported Aug 18, 2021
The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g ,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dutch Ophthalmic USA, Inc.
FDA (openFDA device enforcement)
Reported Aug 18, 2021
Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Edwards Lifesciences, LLC
5 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 18, 2021
Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 18, 2021
HeartWare HVAD Pump Implant Kit, REF 1103
High riskUsing this product could cause serious injury, illness or death — stop using it now.Heartware, Inc.
9 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 18, 2021
CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
FDA (openFDA device enforcement)
Reported Aug 18, 2021
Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, containing expired component NaCl 3000mL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 18, 2021
Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
FDA (openFDA device enforcement)
Reported Aug 18, 2021
Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 18, 2021
Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Neosteo
FDA (openFDA device enforcement)
Reported Aug 18, 2021
Spectrum Medical Quantum Standard heat exchanger
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Qura S.r.l.
FDA (openFDA device enforcement)
Reported Aug 18, 2021
CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Richard Wolf GmbH
FDA (openFDA device enforcement)
Reported Aug 18, 2021
Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208 Intended use: single use accessory devices…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Shent USA, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 18, 2021
Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Simpleware Product Group, SYNOPSYS NORTHERN EUROPE
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 18, 2021
smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew Orthopaedics Ltd. (Aurora)
FDA (openFDA device enforcement)
Reported Aug 18, 2021
Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position, Part…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
18 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 11, 2021
REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c Activated Alanine…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 11, 2021
Sharesource Connectivity Platform for Use with the Amia Automated PD System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 11, 2021
Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 11, 2021
Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Stanbio Laboratory, LP
4 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 11, 2021
Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Straumann USA LLC
FDA (openFDA device enforcement)
Reported Aug 11, 2021
Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast. Sleeve 8-13), Catalog Number 18061407S
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker GmbH
1 more product in this recall
FDA (openFDA device enforcement)
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RecallNow is not a government agency. Every notice above was published by the FDA, USDA FSIS or CPSC and links back to its source. Browse the whole archive.